Trial results for a study investigating cryotherapy for taxane-induced sensory neuropathy in breast cancer patients were posted on ClinicalTrials.gov on 2025-07-28, with 94 participants enrolled.
Background
Breast carcinoma is a common malignancy, and its treatment often involves taxane-based chemotherapy. A significant side effect of taxane therapy is sensory peripheral neuropathy, which can severely impact a patient's quality of life and physical function. This study investigated cryotherapy as a potential method to prevent or improve this taxane-induced neuropathy. The hypothesis was that patients receiving cryotherapy during taxane infusion might experience a lower incidence of peripheral neuropathy, better physical function, and a higher quality of life compared to historical controls.
Trial design
This completed study, designated as Phase NA, enrolled 94 participants. The trial investigated the effect and tolerability of cryotherapy for patients with Breast Carcinoma, specifically aiming to prevent or improve taxane-induced sensory peripheral neuropathy of the hands and feet. The intervention involved the use of Elasto Gel Therapy Mittens and Foot Wraps during taxane infusion. The study aimed to evaluate whether this approach could lead to a lower incidence of peripheral neuropathy, better physical function, and higher quality of life compared to previously reported literature.
Key results
The trial reported key measurements related to the incidence of Chemotherapy Induced Peripheral Neuropathy (CIPN) in the prevention group, which utilized Elasto Gel Therapy Mittens and Foot Wraps:
- For the outcome "Incidence of Chemotherapy Induced Peripheral Neuropathy (CIPN)", the following participant counts were reported in the "Prevention (Elasto Gel Therapy Mittens and Foot Wraps)" group:
- 41 Participants
- 30 Participants
- 25 Participants
What this means
The posted results provide specific participant counts for the incidence of Chemotherapy Induced Peripheral Neuropathy (CIPN) within the cryotherapy intervention group. These numbers reflect the observed incidence in patients using Elasto Gel Therapy Mittens and Foot Wraps during taxane therapy. While the data presents the counts of participants experiencing neuropathy, the absence of comparative data from a control group or statistical analyses limits the ability to draw definitive conclusions regarding the efficacy of cryotherapy in preventing or reducing neuropathy based solely on these results. However, this data contributes to understanding the observed outcomes in patients undergoing this specific cryotherapy intervention.
Source
The information for this condition update was sourced from ClinicalTrials.gov, a public registry of clinical studies. The results for the study NCT04256512, titled "Cryotherapy for the Prevention of Taxane-Induced Sensory Neuropathy of the Hands and Feet in Breast Cancer Patients", were posted on 2025-07-28 on clinicaltrials.gov.